SPIRONOLACTONE

Spironolactone API is a highly effective potassium-sparing diuretic and aldosterone antagonist used in the treatment of edema, hypertension, heart failure, and hyperaldosteronism. It works by inhibiting aldosterone receptors in the distal renal tubules, promoting the excretion of sodium and water while conserving potassium, thus helping maintain electrolyte balance and reducing the risk of hypokalemia associated with other diuretics.

Spironolactone is a core pharmaceutical API used in tablet and capsule formulations, both as a monotherapy and in combination with other antihypertensive agents. It is also utilized in endocrine disorders, such as primary hyperaldosteronism, and for off-label uses in acne and hirsutism in women.

At Bluepill Express, Spironolactone API is manufactured under WHO-GMP, ISO, and cGMP-certified facilities, ensuring the highest standards of purity, stability, and assay accuracy. Every batch undergoes rigorous quality control testing to meet USP / BP / IP pharmacopoeial standards, making it suitable for global pharmaceutical formulation and export.

Therapeutic Applications:

• Management of edema associated with heart failure, liver cirrhosis, and nephrotic syndrome
• Hypertension control as part of combination therapy
• Treatment of primary hyperaldosteronism
• Potassium-sparing diuretic therapy to prevent hypokalemia
• Off-label use in female hirsutism and acne management

Technical Specifications:

• Chemical Name: Spironolactone
• Molecular Formula: C₂₄H₃₂O₄S
• Molecular Weight: 416.56 g/mol
• CAS Number: 52-01-7
• Appearance: White to off-white crystalline powder
• Assay (on dried basis): NLT 99.0%
• Solubility: Practically insoluble in water; soluble in alcohol, chloroform, and methanol
• Melting Point: 134–138°C
• Storage Conditions: Store below 30°C, in a cool, dry place, protected from light and moisture

Pharmacological Action:

Spironolactone acts as a competitive antagonist of aldosterone at mineralocorticoid receptors in the kidney. By blocking aldosterone, it reduces sodium and water reabsorption while retaining potassium and hydrogen ions. This leads to reduced blood pressure, decreased edema, and protection against cardiac and renal remodeling in patients with heart failure.

Manufacturing & Quality Assurance (by Bluepill Express):

• Produced under WHO-GMP, ISO, and cGMP-certified facilities
• Complies with USP / BP / IP pharmacopoeial standards
• Supported with COA, MSDS, and DMF documentation for global regulatory compliance
• High assay value, low impurity profile, and consistent batch-to-batch stability
• Analytical validation using HPLC, IR spectroscopy, and UV analysis
• Exported to regulated and semi-regulated markets worldwide

Advantages of Bluepill Express Spironolactone API:

• High purity and stable crystalline form
• Suitable for tablet and capsule formulations
• Consistent performance in large-scale pharmaceutical production
• Complies with international regulatory standards
• Reliable global supply with regulatory and logistics support